
The U.S. Food and Drug Administration (FDA) announced its decision to ban Red No. 3, a synthetic dye used to create a bright red color in foods and beverages. The additive, linked to cancer in animal studies, will no longer be permitted in food products.
Red No. 3 is currently found in thousands of items, including candies, cereals, fruit cocktail cherries, and strawberry-flavored milkshakes, according to the Center for Science in the Public Interest (CSPI). The food safety advocacy group, which petitioned for the ban in 2022, stated that over 9,200 food items contain the dye, citing data from the Department of Agriculture.
FDA to act:
This decision represents a milestone for advocacy groups and lawmakers who have long urged the FDA to act, citing evidence that the dye’s use in consumables may increase cancer risks and affect children’s behavior. The ban also addresses criticism over the FDA’s previous stance that allowed Red No. 3 in foods while prohibiting its use in cosmetics under the Delaney Clause.
Linda Birnbaum, former director of the National Institute of Environmental Health Sciences, expressed satisfaction with the FDA’s move. “It never made sense to allow this in food when it was banned in cosmetics,” she said. Similarly, Dr. Peter Lurie, president of CSPI, remarked, “At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick but perfectly legal to feed to children in the form of candy.”
Food manufacturers have until January 15, 2027, to remove the dye from their products. Companies producing dietary supplements and other ingestible drugs will have an additional year to comply.
FDA Deputy Commissioner for Human Foods Jim Jones reiterated that the agency could not approve additives found to cause cancer in humans or animals, stating, “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3.” However, the FDA noted that other studies in humans and animals had not demonstrated the same risks, leading to differing views on the dye’s safety.
The National Confectioners Association responded to the announcement, saying that food safety remains a top priority for its members, and they will comply with FDA regulations.
While Red No. 3 is now set to be removed, other synthetic dyes, such as Red No. 40, remain approved, despite being associated with behavioral issues in children. Critics argue that the FDA should evaluate all artificial food dyes to ensure consumer safety.
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